Trial Outcomes & Findings for Effect of Pregabalin on Post Operative Pain in Abdominal Hysterectomy Under Spinal Anesthesia With Intrathecal Morphine (NCT NCT02285010)
NCT ID: NCT02285010
Last Updated: 2019-03-15
Results Overview
Cumulative morphine consumption in the first 24 hours is recorded from IV PCA
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
125 participants
Primary outcome timeframe
6, 12, and 24 hours after operation
Results posted on
2019-03-15
Participant Flow
142 patients on gynecology unit during December 2014 - January 2016 were assessed for eligibility, 17 patient were not randomized due to didn't meet inclusion criteria (n=6), met exclusion criteria (n=4), declined to participate (n=7).
Participant milestones
| Measure |
Placebo
Placebo in capsule is prescribed to the patient 60 min prior to the surgery.
placebo: Placebo in capsule is prescribed to the patient 60 min prior to the surgery.
Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.
|
Pregabalin
Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.
Pregabalin: Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.
Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
62
|
|
Overall Study
COMPLETED
|
58
|
61
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Placebo in capsule is prescribed to the patient 60 min prior to the surgery.
placebo: Placebo in capsule is prescribed to the patient 60 min prior to the surgery.
Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.
|
Pregabalin
Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.
Pregabalin: Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.
Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.
|
|---|---|---|
|
Overall Study
not abdominal hysterectomy
|
2
|
0
|
|
Overall Study
Not spinal anesthesia
|
3
|
1
|
Baseline Characteristics
Effect of Pregabalin on Post Operative Pain in Abdominal Hysterectomy Under Spinal Anesthesia With Intrathecal Morphine
Baseline characteristics by cohort
| Measure |
Placebo
n=58 Participants
Placebo in capsule is prescribed to the patient 60 min prior to the surgery.
placebo: Placebo in capsule is prescribed to the patient 60 min prior to the surgery.
Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.
|
Pregabalin
n=61 Participants
Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.
Pregabalin: Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.
Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.4 years
STANDARD_DEVIATION 6.1 • n=93 Participants
|
45.9 years
STANDARD_DEVIATION 5.3 • n=4 Participants
|
46.2 years
STANDARD_DEVIATION 5.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=93 Participants
|
61 Participants
n=4 Participants
|
119 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
ASA physical status
I
|
35 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
|
ASA physical status
II
|
23 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
57 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6, 12, and 24 hours after operationPopulation: Only 47 and 53 participants from placebo and pregabalin group, respectively, received IV-PCA morphine in the 1st 24 hours. The rest didn't require morphine consumption.
Cumulative morphine consumption in the first 24 hours is recorded from IV PCA
Outcome measures
| Measure |
Placebo
n=47 Participants
Placebo in capsule is prescribed to the patient 60 min prior to the surgery.
placebo: Placebo in capsule is prescribed to the patient 60 min prior to the surgery.
Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.
|
Pregabalin
n=53 Participants
Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.
Pregabalin: Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.
Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.
|
|---|---|---|
|
Post Operative Morphine Consumption
Morphine consumption 6 hr
|
1 mg
Interval 0.0 to 3.3
|
0 mg
Interval 0.0 to 2.0
|
|
Post Operative Morphine Consumption
Morphine consumption 12 hr
|
1 mg
Interval 0.0 to 4.0
|
1 mg
Interval 0.0 to 4.5
|
|
Post Operative Morphine Consumption
Morphine consumption 24 hr
|
4 mg
Interval 1.8 to 10.0
|
5 mg
Interval 2.0 to 11.0
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Only 47 and 53 participants from placebo and pregabalin group, respectively, received IV-PCA morphine in the 1st 24 hours. The rest didn't require morphine consumption.
Time to first analgesia is recorded from IV PCA.
Outcome measures
| Measure |
Placebo
n=47 Participants
Placebo in capsule is prescribed to the patient 60 min prior to the surgery.
placebo: Placebo in capsule is prescribed to the patient 60 min prior to the surgery.
Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.
|
Pregabalin
n=53 Participants
Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.
Pregabalin: Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.
Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.
|
|---|---|---|
|
Time to First Analgesia
|
4.6 hour
Interval 2.1 to 23.9
|
7.7 hour
Interval 2.5 to 23.7
|
SECONDARY outcome
Timeframe: 24 hoursPain score is evaluated by nurses using Numerical Rating Scale (NRS) Minimum score 0 (no pain), Maximum score 10 (worst imaginable pain), lower scores mean a better outcome
Outcome measures
| Measure |
Placebo
n=58 Participants
Placebo in capsule is prescribed to the patient 60 min prior to the surgery.
placebo: Placebo in capsule is prescribed to the patient 60 min prior to the surgery.
Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.
|
Pregabalin
n=61 Participants
Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.
Pregabalin: Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.
Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.
|
|---|---|---|
|
Pain Scores on the Visual Analog Scale
At rest
|
2 score on a scale
Interval 0.0 to 4.0
|
2 score on a scale
Interval 0.0 to 3.0
|
|
Pain Scores on the Visual Analog Scale
At movement
|
4 score on a scale
Interval 2.0 to 6.0
|
4 score on a scale
Interval 3.0 to 5.0
|
SECONDARY outcome
Timeframe: 24 hoursMeasure sedation score by evaluate and observe; measure pruritus, PONV, dizziness, visual disturbance using questionnaire
Outcome measures
| Measure |
Placebo
n=58 Participants
Placebo in capsule is prescribed to the patient 60 min prior to the surgery.
placebo: Placebo in capsule is prescribed to the patient 60 min prior to the surgery.
Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.
|
Pregabalin
n=61 Participants
Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.
Pregabalin: Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.
Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.
|
|---|---|---|
|
Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability
Pruritus · No
|
7 Participants
|
17 Participants
|
|
Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability
Pruritus · Mild
|
35 Participants
|
31 Participants
|
|
Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability
Pruritus · Moderate
|
15 Participants
|
10 Participants
|
|
Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability
Pruritus · Severe
|
1 Participants
|
3 Participants
|
|
Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability
Nausea · No
|
18 Participants
|
23 Participants
|
|
Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability
Nausea · Mild
|
24 Participants
|
21 Participants
|
|
Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability
Nausea · Moderate
|
16 Participants
|
17 Participants
|
|
Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability
Nausea · Severe
|
0 Participants
|
0 Participants
|
|
Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability
Vomiting · No
|
31 Participants
|
38 Participants
|
|
Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability
Vomiting · Mild
|
10 Participants
|
9 Participants
|
|
Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability
Vomiting · Moderate
|
12 Participants
|
8 Participants
|
|
Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability
Vomiting · Severe
|
5 Participants
|
6 Participants
|
|
Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability
Dizziness · No
|
18 Participants
|
14 Participants
|
|
Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability
Dizziness · Mild
|
31 Participants
|
39 Participants
|
|
Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability
Dizziness · Moderate
|
9 Participants
|
7 Participants
|
|
Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability
Dizziness · Severe
|
0 Participants
|
1 Participants
|
|
Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability
Visual disturbance · No
|
51 Participants
|
45 Participants
|
|
Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability
Visual disturbance · Mild
|
7 Participants
|
16 Participants
|
|
Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability
Visual disturbance · Moderate
|
0 Participants
|
0 Participants
|
|
Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability
Visual disturbance · Severe
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 hoursUsing four-point scale to evaluate patient satisfaction. Patients indicated if their satisfaction was Unsatisfied, Less Satisfied, Moderately Satisfied, or Good Satisfied.
Outcome measures
| Measure |
Placebo
n=58 Participants
Placebo in capsule is prescribed to the patient 60 min prior to the surgery.
placebo: Placebo in capsule is prescribed to the patient 60 min prior to the surgery.
Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.
|
Pregabalin
n=61 Participants
Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.
Pregabalin: Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.
Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.
|
|---|---|---|
|
Number of Patients Evaluating Their Satisfaction
Unsatisfied
|
0 Participants
|
0 Participants
|
|
Number of Patients Evaluating Their Satisfaction
Less satisfied
|
1 Participants
|
5 Participants
|
|
Number of Patients Evaluating Their Satisfaction
Moderate satisfied
|
19 Participants
|
25 Participants
|
|
Number of Patients Evaluating Their Satisfaction
Good satisfied
|
38 Participants
|
31 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pregabalin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place